60% of all malignant diseases occur in patients who are 65 years or older. For these patients, aggressive treatments are often not suitable due to reduced life-expectancy, reduced general condition, comorbidities, and reduced vital functions which can lead to increased adverse effects of chemotherapy. Therefore, it is important to investigate alternative therapy options for elderly patients.

Erlotinib is an orally applied medication which is associated with reasonable toxicity. This targeted agent may prove an effective and well-tolerated first-line therapy in elderly patients with advanced non small cell lung cancer.

Therefore, the aim of this study is to investigate the progression-free survival of the combination of vinorelbine and carboplatin in comparison to erlotinib. Given that there will be no significant reduction of efficiency this may provide elderly patients of more than 70 years of age with an active oral substance without subjecting them to the sometimes severe adverse effect of the chemotherapy.

Fertile men must agree to use an effective method of birth control while participating in this study

Signed written informed consent

Exclusion Criteria:

Uncontrolled metastasis in the CNS

Acute, heavy uncontrolled infection

Any other serious concomitant disease or medical condition, which could interfere with participating in this study

Severe hypersensitivity to Erlotinib or any other component

Hypersensitivity to Carboplatin and/or other platinum compounds

Hypersensitivity to Vinorelbin or other Vinca-alkaloids

Patients with a history of other active malignancy in the past 5 years (with the exception of carcinoma in situ of the cervix, non melanomatous skin cancers or local prostate carcinoma that was surgically treated successfully) are excluded.

Participation in another clinical trial with any investigational drug at the same time or within 30 days prior to registration

Psychological, familial, social or geographical situations limiting the compliance with the study requirements

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678964